FDA Device · 2016

FDA Device recalls in 2016

RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.

• American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• PerFuse Decompression Instrument PN: 800-0541, Lot:100650
  FDA Device · Class II · 2016-06-01 · Biomet
• American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants. guide, surgical, instrument
  FDA Device · Class II · 2016-06-01 · Biomet
• American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in)
  FDA Device · Class II · 2016-06-01 · B Braun Medical
• American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• SMR glenosphere impactor/extractor
  FDA Device · Class II · 2016-06-01 · Limacorporate S P A
• American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment
  FDA Device · Class II · 2016-06-01 · Elekta
• American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• GE Healthcare, Discovery IGS 730
  FDA Device · Class II · 2016-06-01 · Ge Medical Systems
• American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012
  FDA Device · Class II · 2016-06-01 · Accriva Diagnostics
• American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve
  FDA Device · Class II · 2016-06-01 · Rti Surgical Dba Pioneer Surgical Technology
• American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line C…
  FDA Device · Class I · 2016-06-01 · Hummingbird Med
• Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and…
  FDA Device · Class II · 2016-06-01 · Angiodynamics Navilyst Medical
• RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis…
  FDA Device · Class II · 2016-06-01 · Raysearch Laboratories Ab
• American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neuro…
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters
  FDA Device · Class II · 2016-06-01 · Stryker Sustainability Solutions
• American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
  FDA Device · Class II · 2016-06-01 · Biomet
• American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2…
  FDA Device · Class II · 2016-06-01 · Ortho Clinical Diagnostics
• American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments tha…
  FDA Device · Class II · 2016-06-01 · Synthes Usa Products
• American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments t…
  FDA Device · Class II · 2016-06-01 · Synthes Usa Products
• Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits
  FDA Device · Class II · 2016-06-01 · Volcano
• American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
  FDA Device · Class II · 2016-06-01 · Roche Molecular Systems
• American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• Various trauma and sports medicine instruments and implants
  FDA Device · Class II · 2016-06-01 · Biomet
• Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are d…
  FDA Device · Class II · 2016-06-01 · Angiodynamics Navilyst Medical
• American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical
• GE Healthcare, Discovery IGS 740
  FDA Device · Class II · 2016-06-01 · Ge Medical Systems
• American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
  FDA Device · Class II · 2016-06-01 · American Surgical

Other years

2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)